Can a protein-mineral drink support bone and muscle health in young basketball players?
| ISRCTN | ISRCTN95632340 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95632340 |
| Sponsor | Chizhou University |
| Funder | Chizhou University |
- Submission date
- 15/05/2026
- Registration date
- 18/05/2026
- Last edited
- 15/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Young basketball players often take part in regular high-intensity training during a period when their bones and muscles are still developing. Good nutrition may help support bone health, muscle function and recovery during this important stage of growth. This study aims to find out whether a daily protein-mineral nutritional supplement can improve markers of bone health and muscle function in adolescent basketball players.
Who can participate?
Adolescent basketball players aged 14 to 18 years who have received systematic basketball training for at least 3 years and currently train for at least 15 hours per week may participate. Participants must be in good general health, able to complete the study tests and have written consent from both themselves and their legal guardians.
What does the study involve?
Participants are randomly assigned to one of two groups. One group receives a daily protein-mineral nutritional supplement for 16 weeks. The other group receives a placebo drink that looks and tastes the same but does not contain the active nutritional ingredients. Neither the participants nor the researchers know which group each participant is in until the study is completed. Blood tests, bone assessments, muscle strength tests and performance tests are carried out to compare changes between the two groups.
What are the possible benefits and risks of participating?
Participants may benefit from closer monitoring of their bone health, muscle function and training-related health indicators. The nutritional supplement may help support musculoskeletal health, although this cannot be guaranteed. Possible risks include mild gastrointestinal discomfort, such as bloating, nausea or diarrhoea. Blood sampling may cause temporary discomfort, bruising or light-headedness. Safety indicators are monitored throughout the study.
Where is the study run from?
Chizhou University (China)
When is the study starting and how long is it expected to run for?
September 2024 to May 2025
Who is funding the study?
Chizhou University (China)
Who is the main contact?
Lei He, 1140907063@qq.com
Contact information
Public, Scientific
Wanju-gun 55338, Jeollabuk-do
Wanju-gun
55338
Korea, South
| Phone | +82 (0)1058363886 |
|---|---|
| 1140907063@qq.com |
Public
No. 998 Fangxing Avenue, Hefei Economic and Technological Development Zone
HeFei
230061
China
| Phone | +82 (0)17681204090 |
|---|---|
| 19154011075@163.com |
Principal investigator
No. 1180, Shuanggang East Street, Changbei Development Zone
Nanchang
330013
China
| Phone | +82 (0)17681204090 |
|---|---|
| huangqinshan@jxust.edu.cn |
Scientific
No. 199, Muzhilu Road, Guichi District
Chizhou
247000
China
| Phone | +82 (0)17681204090 |
|---|---|
| 936667979@qq.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Crossover |
| Purpose | Treatment |
| Scientific title | Effects of a 16-week multi-component protein-mineral supplement on bone turnover and muscle function in adolescent basketball players: a randomized double-blind placebo-controlled trial |
| Study objectives | The primary objective of this study is to evaluate the effect of a 16-week multi-component protein-mineral nutritional supplement on bone turnover in adolescent basketball players undergoing high-intensity training. Secondary objectives are to assess changes in bone microstructure, bone mineral density, muscle strength, functional performance, and safety/tolerability. Exploratory objectives are to investigate potential muscle-bone adaptive responses, including changes in myokines, osteokines, and related regulatory biomarkers. |
| Ethics approval(s) |
Approved 01/08/2024, Research Ethics Committee of Chizhou University (No. 199, Muzhilu Road, Guichi District, Chizhou, 247200, China; +82 (0)5662748827; czxyjy@czu.edu.cn), ref: CZ20240801 |
| Health condition(s) or problem(s) studied | Bone metabolic stress, suboptimal musculoskeletal adaptation, and muscle function changes associated with high-intensity training in adolescent basketball players |
| Intervention | Eligible participants are randomly assigned in a 1:1 ratio to either the intervention group or the placebo group. The randomisation sequence is generated by an independent statistician using a computer-generated random number table. Block randomisation with a block size of 4 is used, stratified by sex and age group, namely 14–16 years and 17–18 years. Allocation is implemented using sealed, opaque, sequentially numbered envelopes. Participants in the intervention group receive a daily multi-component protein-mineral nutritional supplement for 16 weeks. Each serving contains 28 g of protein, including whey protein and collagen protein, combined with calcium, phosphorus, magnesium, vitamin D3, vitamin K2, lactoferrin and casein phosphopeptides. The supplement is taken within 30 minutes after training or after breakfast on non-training days. Participants in the placebo group receive an isocaloric maltodextrin placebo for 16 weeks. The placebo has an identical appearance, taste and packaging to the intervention product. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. Serum C-terminal telopeptide of type I collagen concentration (CTX-1) measured from fasting morning blood samples using a validated laboratory immunoassay at baseline and week 16. |
| Completion date | 15/05/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 14 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 14–18 years 2. Male or female adolescent basketball players 3. Systematic basketball training for ≥3 years 4. Current training volume ≥15 hours/week 5. Bone age within 1 year of chronological age 6. Good general health and able to complete all study assessments 7. Written informed consent from both participant and legal guardian |
| Key exclusion criteria | 1. History of metabolic bone disease 2. Fracture within the past 6 months 3. Endocrine disorders affecting bone metabolism 4. Use of medications affecting bone metabolism within the past 3 months 5. Severe gastrointestinal disease 6. Allergy to study product ingredients 7. Participation in another clinical trial during the study period |
| Date of first enrolment | 15/09/2024 |
| Date of final enrolment | 15/12/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
15/05/2026: Study's existence confirmed by the Research Ethics Committee of Chizhou.
